Location: Burlington, MA
Job ID: 170664-1A
Date Posted: Sep 14, 2021
Category: Clinical Professional
Welcome to Lahey Hospital & Medical Center, part of Beth Israel Lahey Health. Lahey Hospital & Medical Center is a world-renowned tertiary medical center known for its innovative technology, pioneering medical treatment and leading-edge research. A teaching hospital of Tufts University School of Medicine, the hospital provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation. It is a national leader in a number of health care areas, including stroke, weight management and lung screenings, among many others. Lahey also helps to advance medicine through research and the education of tomorrow's health care leaders.
About the Job
Under general direction will be responsible for managing, promoting, cultivating and overseeing all aspects of research including management of a clinical research department(s).
Essential Duties & Responsibilities including but not limited to:
1) Manages and oversees a clinical research program(s).
2) Leads the department in all aspects of the daily research operation:
a) Directly supervises the day-to-day operations of research providing direction and support to staff as needed.
b) Oversees and ensures staff compliance with the research protocols of the department.
c) Utilizes problem-solving skills and creates a proactive work environment in the maintenance of optimal department functioning.
d) Evaluates and revises departmental research practices and procedures.
e) Coordinates and facilitates research project team meetings, including creating agendas and generating minutes and action items.
3) Possesses direct knowledge and experience in the implementation of all aspects of clinical trials research complying with research SOPs, GCP, FDA and OHRP regulations; ensures adherence to regulations and educates study team members.
4) Functions as a resource and educator for research study team members and other colleagues related to research conducted within the department:
a) Acquires detailed knowledge of studies so to serve as a specialist; Grasps the scope and objectives of projects.
b) Triages calls from physicians, nurses, research staff or other colleagues.
c) Educates investigators and ensures necessary and up- to- date trainings as applicable (e.g., CITI certifications).
d) Evaluates and recommends recruitment efforts and practices.
e) Monitors study enrollment; Identifies and addresses recruitment barriers.
f) Manages conflict.
5) Expands research opportunities by soliciting sponsors and CRO’s for new trials:
a) Actively seeks new research opportunities.
b) Completes and submits trial feasibility forms; coordinates and obtains non-disclosure agreements.
c) Reviews new protocols for feasibility, capability, logistics, personnel needs, etc.
d) Establishes relationships with sponsors and/or CROs.
e) Arranges and/or conducts pre-study qualification and site visits.
6) Develops new research initiatives in collaboration with physicians and sponsors; project management:
a) Assists physicians with study protocol development; development and management of single center and/or multicenter projects as a sponsor- investigator.
b) Assists in designing studies of drug utilization, clinical practices, and patient care processes.
c) Assists with chart review submissions and implementation.
d) Designs and implements improvement projects based on study results.
7) Actively involved in development of research trial budgets:
a) Works closely with Research Finance to develop appropriate budget and contract preparation and negotiation.
b) Works collaboratively with Research Finance to oversee Medicare compliance in research visit billing.
c) Monitors research budget and corresponding enrollment status.
d) Ensures research staff is operating within budget constraints.
e) Assists with the acquisition, development, submission and maintenance of grants; Seeks out funding opportunities.
8) Assists in preparing summary reports, study results, poster presentations and manuscripts for publication; Reviews scientific literature.
9) Maintains an up-to-date listing of research activities, including research publications and presentations.
10) Assists with statistical planning and analysis, as applicable; Functions as a liaison between statisticians and physicians.
11) Participates in continuing education activities and attends conferences/seminars to maintain current knowledge of clinical study affairs and issues.
12) Participates and assists in other research projects and initiatives as necessary.
a) Is a team player within the department.
b) Is flexible with time when applicable.
Maintain strict adherence to the Lahey Hospital and Medical Center Confidentiality policy.
Incorporate Lahey Hospital and Medical Center Standards of Behavior and Guiding Principles into daily activities.
Comply with all Lahey Hospital and Medical Center Policies.
Comply with behavioral expectations of the department and Lahey Hospital and Medical Center.
Maintain courteous and effective interactions with colleagues and patients.
Demonstrate an understanding of the job description, performance expectations, and competency assessment.
Demonstrate a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.
Participate in departmental and/or interdepartmental quality improvement activities.
Participate in and successfully completes Mandatory Education.
Perform all other duties as needed or directed to meet the needs of the department.
Education: Master’s degree required. -or- Bachelor’s degree and CCRP/CCRC certification (or equivalent certification) required.
Licensure, Certification & Registration: CCRP/CCRC certification or equivalent certification required in the absence of a Master’s degree.
Experience: 7+ years direct work related experience in a research setting; leadership and project management experience required; Epic experience a plus.
Skills, Knowledge & Abilities:
Ability to make decisions with significant, broad implications for the management of a major department or multiple departments;
Ability to set goals and priorities;
Ability to function independently, take initiative and make decisions that are guided by general instructions and practices requiring some interpretation; *Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observations, knowledge and skills based on general precedents;
Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations;
Strong verbal and written communication, multi-tasking, attention to detail and organizational skills;
Ability to interact with professional personnel at all levels of an organization; *Ability to communicate clearly and effectively and work collaboratively in small teams;
Ability to demonstrate a positive and respectful attitude using skills in active listening and problem solving;
Experience with computer systems, including web based applications required;
In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.
Beth Israel Lahey Health is dedicated to improving health and wellness and making a difference in the lives of our patients, their families and all members of the communities we serve. Formed in March 2019, Beth Israel Lahey Health is a patient-centered, integrated care delivery system providing a continuum of services spanning academic, tertiary and community hospitals, dedicated orthopedic and psychiatric hospitals, primary and specialty care, community acute care, ambulatory care, behavioral services and home health. Beth Israel Lahey Health Performance Network is a unified joint contracting and population health management organization, jointly governed by participating physicians and hospitals.
Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.